GORE VIABAHN VBX Balloon Expandable Endo BXB055902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132658343), received between Sep 4, 2025 and Sep 28, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (P160021); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 1, 2024Class IIOpen, Classified

   Due to packaging defects, sterility assurance and heparin activity may be compromised.

   Z-2945-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Partial Blockage; Complete Blockage

  Patient problems: Insufficient Information; Obstruction/Occlusion; Restenosis

  MAUDE report 50918245 ↗
• InjuryAug 6, 2026Partial Blockage

  The following information was reported through the AAA 24-01 TAMBE Post Approval Study:On (b)(6) 2026, the patient underwent endovascular procedure to treat a thoracoabdominal aortic aneurysm using a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) device system and GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX device).During the index procedure, a suspected left kidney embolism was identified, which was then confirmed one day postop. Subsequently, the patient experienced left renal artery stent thrombosis, due to mural thrombus from the aneurysm embolizing the left renal artery. The patient was placed on anticoagulation therapy to prevent further thrombosis.FMAR code 2203 - other, used to capture thrombosis.

  Patient problems: Obstruction/Occlusion

  MAUDE report 50160800 ↗
• InjurySep 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE RIGHT AND LEFT RENAL ARTERIES WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON (B)(6) 2025, REPORTEDLY, THE PATIENT HAD VERY SMALL RENAL VESSELS AND WERE SHUT DOWN FOR OVER 24 HOURS. THE PHYSICIAN ATTEMPTED A REINTERVENTION ON BOTH RENAL ARTERIES. IT APPEARED THAT BOTH VBX DEVICE'S MAY HAVE BEEN COMPRESSED (POSSIBLY BY AN AORTIC BALLOON). THE PHYSICIAN COULD ONLY GET ACCESS INTO THE RIGHT RENAL BECAUSE OF TORTUOSITY. THE RIGHT RENAL ARTERY WAS DECLOTTED WITH TISSUE PLASMINOGEN ACTIVATOR AND PENUMBRA DEVICE AND THEN A VBX DEVICE WAS PLACED TO MAKE SURE IT STAYS OPEN. THE RIGHT RENAL LOOKED GREAT ANGIOGRAPHICALLY AFTER THE PROCEDURE. POST PROCEDURE - PATIENT RECOVERING. THE PHYSICIAN PLACED A DIALYSIS CATHETER INTO THE PATIENT FOR USE. ON (B)(6) 2025, THE PATIENT WAS NOT MAKING URINE. NO FURTHER UPDATES WERE PROVIDED.

  Patient problems: Renal Failure

  MAUDE report 22973237 ↗
• InjurySep 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF THE RIGHT AND LEFT RENAL ARTERIES WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON (B)(6) 2025, REPORTEDLY, THE PATIENT HAD VERY SMALL RENAL VESSELS AND WERE SHUT DOWN FOR OVER 24 HOURS. THE PHYSICIAN ATTEMPTED A REINTERVENTION ON BOTH RENAL ARTERIES. IT APPEARED THAT BOTH VBX DEVICE'S MAY HAVE BEEN COMPRESSED (POSSIBLY BY AN AORTIC BALLOON). THE PHYSICIAN COULD ONLY GET ACCESS INTO THE RIGHT RENAL BECAUSE OF TORTUOSITY. THE RIGHT RENAL ARTERY WAS DECLOTTED WITH TISSUE PLASMINOGEN ACTIVATOR AND PENUMBRA DEVICE AND THEN A VBX DEVICE WAS PLACED TO MAKE SURE IT STAYS OPEN. THE RIGHT RENAL LOOKED GREAT ANGIOGRAPHICALLY AFTER THE PROCEDURE. POST PROCEDURE - PATIENT RECOVERING. THE PHYSICIAN PLACED A DIALYSIS CATHETER INTO THE PATIENT FOR USE. ON (B)(6) 2025, THE PATIENT WAS NOT MAKING URINE. NO FURTHER UPDATES WERE PROVIDED.

  Patient problems: Renal Failure

  MAUDE report 22972290 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160021. One submission often covers many models, so check the product and lot details in each record.

• Z-0077-2022 · Sep 7, 2021 · Open, Classified
  Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diame